9
Participants
Start Date
September 29, 2017
Primary Completion Date
April 18, 2018
Study Completion Date
April 18, 2018
Transfusion of rejuvenated and washed autolgous RBCs
Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
Transfusion of washed autolgous RBCs
Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
Duke University Medical Center, Durham
Lead Sponsor
Collaborators (1)
Zimmer Biomet
INDUSTRY
Duke University
OTHER